Type 2 diabetes

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Recruiting · 2 sites across 2 states

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is: Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)? Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care. Participants will: Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Adults older than 18 and younger than 89
•Have type 1 diabetes for at least 1 year and use insulin for at least 1 year, or have type 2 diabetes and be on injected/infused insulin for at least 3 months
•Have stable diabetes medicine doses (including GLP-1 medicines) for the past 4 weeks
•Be able to use the required devices (iLet system and Dexcom CGM) and follow the study steps
•If pregnancy is possible: agree to pregnancy testing and use acceptable birth control during the study

🚫 You may not be able to join if…

•Cannot safely follow study steps or reporting (for example vision/dexterity or memory problems that block safe use)
•Cannot speak and read English
•Have MODY (maturity-onset diabetes of the young)
•Plan to change their diabetes treatment during the study in ways that would affect regimen (such as switching insulin methods, starting a new type of diabetes drug, or starting/increasing GLP-1 or GLP-1/GIP medicines)
•Pregnant or breastfeeding (or planning pregnancy in the next 6 months)

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 18–89
✓Have Type 2 diabetes

!Some conditions may not be a fit: Heart / cardiovascular disease, Kidney disease
!Not for people who are pregnant or breastfeeding
!May require a break from current GLP-1 medications

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

I take a GLP-1 medication (like Ozempic or Wegovy). Can I still join?+

Maybe. This study may ask you to pause certain weight or diabetes medications for a period of time (a 'washout') before joining, or it may be looking for people not currently on them. The coordinator will review your medications with you — don't stop any medication on your own.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT07011147 · Locations: Colorado · Massachusetts